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Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).
GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).
NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastroesophageal reflux disease (GERD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| symptom questionaire | Other | GerdQ questionaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Association of Each Endoscopic Finding With Symptom Score | Symptom score is assessed by a self-reported questionnaire | 1 month |
| Association of Each Endoscopic Finding With pH Monitoring Result |
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Inclusion criteria
Exclusion criteria:
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Patients presented with reflux symptoms in outpatient clinic of a general hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Shuzhang Li, MD | Chinese PLA General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outpatient Department Building | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18852068 | Result | Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gastroesophageal Reflux Disease (GERD) | symptom questionaire: GerdQ questionaire pH monitoring: 24-hour pH monitoring Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI rabeprazole: 10mg, bid, p.o. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gastroesophageal Reflux Disease (GERD) | symptom questionaire: GerdQ questionaire pH monitoring: 24-hour pH monitoring Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI rabeprazole: 10mg, bid, p.o. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | Diagnostic capabilities of WLI in the diagnosis of GERD |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Weifeng Wang | ChinaPLAGH | 0086-13911952018 | wangwf301@hotmail.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| pH monitoring | Procedure | 24-hour pH monitoring |
|
|
| Tri-modal imaging endoscopy | Procedure | To investigate WLI,NBI and AFI |
|
|
| rabeprazole | Drug | 10mg, bid, p.o. |
|
|
| 1 month |
| Association of Each Endoscopic Finding With Treatment Effect of PPI | Treatment effect of PPI is assessed by changes of symptom score | 2 month |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Diagnostic capabilities of GerdQ in the diagnosis of GERD |
|
|
| Secondary | Association of Each Endoscopic Finding With Symptom Score | Symptom score is assessed by a self-reported questionnaire | Not Posted | 1 month |
| Secondary | Association of Each Endoscopic Finding With pH Monitoring Result | Not Posted | 1 month |
| Secondary | Association of Each Endoscopic Finding With Treatment Effect of PPI | Treatment effect of PPI is assessed by changes of symptom score | Not Posted | 2 month |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Participants Same to arm1 | Diagnostic capabilities of AFI in the diagnosis of GERD | 0 | 0 | 0 | 0 |
| EG002 | Participants Same to Previous Arm | Diagnostic capabilities of GerdQ in the diagnosis of GERD | 0 | 0 | 0 | 0 |
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| D004066 | Digestive System Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |